Guide apparatus for delivery of a flexible instrument and methods of use

ABSTRACT

A guiding apparatus comprises a support assembly extending along a longitudinal axis and including a first plurality of linkages and a second plurality of linkages. The first plurality of linkages includes a first channel formation and the second plurality of linkages includes a second channel formation. The support assembly has a coupled configuration with a proximal end and a distal end in which the first plurality of linkages is coupled to the second plurality of linkages with the first and second channel formations arranged to form a continuous channel through the support assembly. The continuous channel has an opening sized to receive an elongated flexible instrument.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/276,153, filed May 13, 2014, which claims the benefit of U.S.Provisional Application 61/823,666 filed May 15, 2013, entitled “GUIDEAPPARATUS FOR DELIVERY OF A FLEXIBLE INSTRUMENT AND METHODS OF USE.” Thecontents of each of the above-listed applications are incorporated byreference herein in their entirety.

FIELD

The present disclosure is directed to systems and methods for navigatinga patient anatomy to conduct a minimally invasive procedure, and moreparticularly to apparatus and methods for guiding and supportingdelivery of a flexible interventional instrument into a patient anatomy.

BACKGROUND

Minimally invasive medical techniques are intended to reduce the amountof tissue that is damaged during interventional procedures, therebyreducing patient recovery time, discomfort, and deleterious sideeffects. Such minimally invasive techniques may be performed throughnatural orifices in a patient anatomy or through one or more surgicalincisions. Through these natural orifices or incisions clinicians mayinsert interventional instruments (including surgical, diagnostic,therapeutic, or biopsy instruments) to reach a target tissue location.To reach the target tissue location, a minimally invasive interventionalinstrument may navigate natural or surgically created passageways inanatomical systems such as the lungs, the colon, the intestines, thekidneys, the heart, the circulatory system, or the like. Roboticinterventional systems may be used to insert the interventionalinstruments into the patient anatomy. In existing systems, the length ofthe interventional instrument extending between the patient and arobotic manipulator is unsupported which may cause the instrument tobend and buckle as it is inserted into the patient anatomy. Deformationof the instrument may damage internal components such as optical fibershape sensors or endoscopic equipment. Improved systems and methods areneeded for guiding and supporting interventional instruments as they areinserted into a patient anatomy to prevent instrument deformation.

SUMMARY

The embodiments of the invention are summarized by the claims thatfollow the description.

In one embodiment, an apparatus for guiding a flexible instrumentcomprises an elongated support assembly having a longitudinal axis. Theelongated support assembly is adapted to laterally receive intoengagement and longitudinally support an elongated flexible instrument.

In another embodiment, a guiding apparatus comprises an elongatedsupport assembly extending along a longitudinal axis and having aproximal end and a distal end. The elongated support assembly includes afirst support member including a channel formation and a second supportmember including a channel formation. The second support member iscoupled to the first support member along the longitudinal axis with thechannel formations of the first and second support members joined toform a continuous open channel through the support assembly. Advancementof the proximal end of the support assembly along the longitudinal axisseparates the distal end of the support assembly, directing separateddistal ends of the first and second support members away from thelongitudinal axis.

In another embodiment, a guiding apparatus comprises a support assemblyincluding a first plurality of linkages and a second plurality oflinkages, each of the linkages of the first and second pluralities oflinkages includes a channel formation. The support assembly has acoupled configuration with a proximal end and a distal end in which thefirst plurality of linkages is coupled to the second plurality oflinkages with the channel formations arranged to form a continuouschannel through the support assembly.

In another embodiment, a method of guiding an interventional instrumentcomprises providing an elongated support assembly extending along alongitudinal axis and having a proximal end and a distal end. Thesupport assembly includes a first support member including a channelformation and a second support member including a channel formation. Thesecond support member is coupled to the first support member along thelongitudinal axis with the channel formations of the first and secondsupport members joined to form a continuous channel through the supportassembly. The method further comprises receiving a portion of theinterventional instrument through an elongated opening of the continuouschannel and moving the interventional instrument in a first directionalong the longitudinal axis. The method further comprises separating aportion of the first support member from a portion of the second supportmember and directing the separated portions of the first and secondsupport members away from the longitudinal axis.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTIONS OF THE DRAWINGS

Aspects of the present disclosure are best understood from the followingdetailed description when read with the accompanying figures. It isemphasized that, in accordance with the standard practice in theindustry, various features are not drawn to scale. In fact, thedimensions of the various features may be arbitrarily increased orreduced for clarity of discussion. In addition, the present disclosuremay repeat reference numerals and/or letters in the various examples.This repetition is for the purpose of simplicity and clarity and doesnot in itself dictate a relationship between the various embodimentsand/or configurations discussed.

FIG. 1 is a robotic interventional system, in accordance with anembodiment of the present disclosure.

FIG. 2 illustrates an interventional instrument system utilizing aspectsof the present disclosure.

FIG. 3 is a side view of a robotic assembly and an instrument guidingapparatus according to an embodiment of the present invention.

FIG. 4 illustrates the distal end of the instrument guiding apparatus ofFIG. 3 in an initial configuration.

FIG. 5 illustrates the distal end of the instrument guiding apparatus ofFIG. 3 in an operating configuration.

FIG. 6a illustrates an oblique view of a linkage element according to anembodiment of the present invention.

FIG. 6b illustrates a side view of the linkage element of FIG. 6 a.

FIG. 7 illustrates the distal end of the instrument guiding apparatus ofFIG. 3 and a mounting strut coupling the guiding apparatus to therobotic assembly.

FIG. 8 is an oblique view of the robotic assembly and the instrumentguiding apparatus of FIG. 3.

FIGS. 9a and 9b illustrate the effect of linkage size on chordal actionaround a return assembly.

FIG. 10 is a side view of an interventional instrument coupled to arobotic assembly and an instrument guiding apparatus according to anembodiment of the present invention.

FIG. 11 illustrates the interventional instrument and instrument guidingapparatus of FIG. 10 coupled to a robotic assembly in a patientenvironment according to an embodiment of the present invention.

FIG. 12 is a flowchart describing a method of guiding an interventionalinstrument according to an embodiment of the present disclosure.

FIG. 13 illustrates a robotic assembly and an instrument guidingapparatus according to another embodiment of the present disclosure.

DETAILED DESCRIPTION

In the following detailed description of the aspects of the invention,numerous specific details are set forth in order to provide a thoroughunderstanding of the disclosed embodiments. However, it will be obviousto one skilled in the art that the embodiments of this disclosure may bepracticed without these specific details. In other instances well knownmethods, procedures, components, and circuits have not been described indetail so as not to unnecessarily obscure aspects of the embodiments ofthe invention. And, to avoid needless descriptive repetition, one ormore components or actions described in accordance with one illustrativeembodiment can be used or omitted as applicable from other illustrativeembodiments.

The embodiments below will describe various instruments and portions ofinstruments in terms of their state in three-dimensional space. As usedherein, the term “position” refers to the location of an object or aportion of an object in a three-dimensional space (e.g., three degreesof translational freedom along Cartesian X, Y, Z coordinates). As usedherein, the term “orientation” refers to the rotational placement of anobject or a portion of an object (three degrees of rotationalfreedom—e.g., roll, pitch, and yaw). As used herein, the term “pose”refers to the position of an object or a portion of an object in atleast one degree of translational freedom and to the orientation of thatobject or portion of the object in at least one degree of rotationalfreedom (up to six total degrees of freedom). As used herein, the term“shape” refers to a set of poses, positions, or orientations measuredalong an elongated object.

Referring to FIG. 1 of the drawings, a robotic interventional system foruse in, for example, surgical, diagnostic, therapeutic, or biopsyprocedures, is generally indicated by the reference numeral 100. Asshown in FIG. 1, the robotic interventional system 100 generallyincludes a robotic assembly 102 mounted to or near an operating table Oon which a patient P is positioned. An interventional instrument system104 is operably coupled to the robotic assembly 102. An operator inputsystem 106 allows a surgeon S to view the surgical site and to controlthe operation of the interventional instrument system 104.

The operator input system 106 may be located at a surgeon's consolewhich is usually located in the same room as operating table O. However,it should be understood that the surgeon S can be located in a differentroom or a completely different building from the patient P. Operatorinput system 106 generally includes one or more control device(s) forcontrolling the interventional instrument system 104. The controldevice(s) may include any number of a variety of input devices, such ashand grips, joysticks, trackballs, data gloves, trigger-guns,hand-operated controllers, voice recognition devices, touch screens,body motion or presence sensors, or the like. In some embodiments, thecontrol device(s) will be provided with the same degrees of freedom asthe interventional instruments of the robotic assembly to provide thesurgeon with telepresence, or the perception that the control device(s)are integral with the instruments so that the surgeon has a strong senseof directly controlling instruments. In other embodiments, the controldevice(s) may have more or fewer degrees of freedom than the associatedinterventional instruments and still provide the surgeon withtelepresence. In some embodiments, the control device(s) are manualinput devices which move with six degrees of freedom, and which may alsoinclude an actuatable handle for actuating instruments (for example, forclosing grasping jaws, applying an electrical potential to an electrode,delivering a medicinal treatment, or the like).

The robotic assembly 102 supports the interventional instrument system104 and may comprise a kinematic structure of one or more non-servocontrolled links (e.g., one or more links that may be manuallypositioned and locked in place, generally referred to as a set-upstructure) and a robotic manipulator. The robotic assembly 102 includesplurality of actuators (e.g., motors) that drive inputs on theinterventional instrument 104. These motors actively move in response tocommands from the control system (e.g., control system 112). The motorsinclude drive systems which when coupled to the interventionalinstrument 104 may advance the interventional instrument into anaturally or surgically created anatomical orifice and/or may move thedistal end of the interventional instrument in multiple degrees offreedom, which may include three degrees of linear motion (e.g., linearmotion along the X, Y, Z Cartesian axes) and three degrees of rotationalmotion (e.g., rotation about the X, Y, Z Cartesian axes). Additionally,the motors can be used to actuate an articulable end effector of theinstrument for grasping tissue in the jaws of a biopsy device or thelike.

The robotic interventional system 100 also includes a sensor system 108with one or more sub-systems for receiving information about theinstruments of the robotic assembly. Such sub-systems may include aposition sensor system (e.g., an electromagnetic (EM) sensor system); ashape sensor system for determining the position, orientation, speed,pose, and/or shape of the catheter tip and/or of one or more segmentsalong a flexible body of instrument 104; and/or a visualization systemfor capturing images from the distal end of the catheter system.

The robotic interventional system 100 also includes a display system 110for displaying an image of the surgical site and interventionalinstruments 104 generated by sub-systems of the sensor system 108. Thedisplay 110 and the operator input system 106 may be oriented so theoperator can control the interventional instrument system 104 and theoperator input system 106 as if viewing the workspace in substantiallytrue presence. True presence means that the displayed tissue imageappears to an operator as if the operator was physically present at theimage location and directly viewing the tissue from the perspective ofthe image.

Alternatively or additionally, display system 110 may present images ofthe surgical site recorded and/or modeled preoperatively using imagingtechnology such as computerized tomography (CT), magnetic resonanceimaging (MRI), fluoroscopy, thermography, ultrasound, optical coherencetomography (OCT), thermal imaging, impedance imaging, laser imaging,nanotube X-ray imaging, or the like. The presented preoperative imagesmay include two-dimensional, three-dimensional, or four-dimensional(including e.g., time based or velocity based information) images andmodels.

In some embodiments, the display system 110 may display a virtualvisualization image in which the actual location of the interventionalinstrument is registered (e.g., dynamically referenced) withpreoperative or concurrent images to present the surgeon with a virtualimage of the internal surgical site at the location of the tip of thesurgical instrument.

In other embodiments, the display system 110 may display a virtualvisualization image in which the actual location of the interventionalinstrument is registered with prior images (including preoperativelyrecorded images) or concurrent images to present the surgeon with avirtual image of an interventional instrument at the surgical site. Animage of a portion of the interventional instrument 104 may besuperimposed on the virtual image to assist the surgeon controlling theinterventional instrument.

The robotic interventional system 100 also includes a control system112. The control system 112 includes at least one processor (not shown),and typically a plurality of processors, for effecting control betweenthe interventional instrument system 104, the operator input system 106,the sensor system 108, and the display system 110. The control system112 also includes programmed instructions (e.g., a computer-readablemedium storing the instructions) to implement some or all of the methodsdescribed herein. While control system 112 is shown as a single block inthe simplified schematic of FIG. 1, the system may comprise a number ofdata processing circuits with a portion of the processing optionallybeing performed on or adjacent the robotic assembly 102, a portion beingperformed at the operator input system 106, and the like. Any of a widevariety of centralized or distributed data processing architectures maybe employed. Similarly, the programmed instructions may be implementedas a number of separate programs or subroutines, or they may beintegrated into a number of other aspects of the robotic systemsdescribed herein. In one embodiment, control system 112 supportswireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE802.11, DECT, and Wireless Telemetry.

In some embodiments, control system 112 may include one or more servocontrollers to provide force and torque feedback from the interventionalinstrument system 104 to one or more corresponding servomotors for theoperator input system 106. The servo controller(s) may also transmitsignals instructing robotic assembly 102 to move the interventionalinstruments 104 which extend into an internal surgical site within thepatient body via openings in the body. Any suitable conventional orspecialized servo controller may be used. A servo controller may beseparate from, or integrated with, robotic assembly 102. In someembodiments, the servo controller and robotic assembly are provided aspart of a robotic arm cart positioned adjacent to the patient's body.

The control system 112 may further include a virtual visualizationsystem to provide navigation assistance to the interventionalinstruments 104. Virtual navigation using the virtual visualizationsystem is based upon reference to an acquired dataset associated withthe three dimensional structure of the anatomical passageways. Morespecifically, the virtual visualization system processes images of thesurgical site recorded and/or modeled using imaging technology such ascomputerized tomography (CT), magnetic resonance imaging (MRI),fluoroscopy, thermography, ultrasound, optical coherence tomography(OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-rayimaging, or the like. Software is used to convert the recorded imagesinto a two dimensional or three dimensional model of a partial or anentire anatomical organ or anatomical region. The model describes thevarious locations and shapes of the passageways and their connectivity.The images used to generate the model may be recorded preoperatively orintra-operatively during a clinical procedure. In an alternativeembodiment, a virtual visualization system may use standard models(i.e., not patient specific) or hybrids of a standard model and patientspecific data. The model and any virtual images generated by the modelmay represent the static posture of a deformable anatomic region duringone or more phases of motion (e.g., during an inspiration/expirationcycle of a lung).

During a virtual navigation procedure, the sensor system 108 may be usedto compute an approximate location of the instrument with respect to thepatient anatomy. The location can be used to produce both macro-leveltracking images of the patient anatomy and virtual internal images ofthe patient anatomy. Various systems for using fiber optic sensors toregister and display an interventional implement together withpreoperatively recorded surgical images, such as those from a virtualvisualization system, are known. For example U.S. patent applicationSer. No. 13/107,562, filed May 13, 2011, disclosing, “Medical SystemProviding Dynamic Registration of a Model of an Anatomical Structure forImage-Guided Surgery,” which is incorporated by reference herein in itsentirety, discloses one such system.

The robotic interventional system 100 may further include optionaloperation and support systems (not shown) such as illumination systems,steering control systems, irrigation systems, and/or suction systems. Inalternative embodiments, the robotic system may include more than onerobotic assembly and/or more than one operator input system. The exactnumber of manipulator assemblies will depend on the surgical procedureand the space constraints within the operating room, among otherfactors. The operator input systems may be collocated, or they may bepositioned in separate locations. Multiple operator input systems allowmore than one operator to control one or more manipulator assemblies invarious combinations.

FIG. 2 illustrates an interventional instrument system 200 which may beused as the interventional instrument system 104 of roboticinterventional system 100. Alternatively, the interventional instrumentsystem 200 may be used for non-robotic exploratory procedures or inprocedures involving traditional manually operated interventionalinstruments, such as endoscopy.

The instrument system 200 includes a catheter system 202 coupled to aninstrument body 204. The catheter system 202 includes an elongatedflexible catheter body 216 having a proximal end 217 and a distal end218. In one embodiment, the flexible body 216 has an approximately 3 mmouter diameter. Other flexible body outer diameters may be larger orsmaller. The catheter system 202 may optionally include a shape sensor222 for determining the position, orientation, speed, pose, and/or shapeof the catheter tip at distal end 218 and/or of one or more segments 224along the body 216. The entire length of the body 216, between thedistal end 218 and the proximal end 217 may be effectively divided intothe segments 224. If the instrument system 200 is an interventionalinstrument system 104 of a robotic interventional system 100, the shapesensor 222 may be a component of the sensor system 108. If theinstrument system 200 is manually operated or otherwise used fornon-robotic procedures, the shape sensor 222 may be coupled to atracking system that interrogates the shape sensor and processes thereceived shape data.

The shape sensor system 222 may include an optical fiber aligned withthe flexible catheter body 216 (e.g., provided within an interiorchannel (not shown) or mounted externally). In one embodiment, theoptical fiber has a diameter of approximately 200 μm. In otherembodiments, the dimensions may be larger or smaller.

The optical fiber of the shape sensor system 222 forms a fiber opticbend sensor for determining the shape of the catheter system 202. In onealternative, optical fibers including Fiber Bragg Gratings (FBGs) areused to provide strain measurements in structures in one or moredimensions. Various systems and methods for monitoring the shape andrelative position of an optical fiber in three dimensions are describedin U.S. patent application Ser. No. 11/180,389, filed Jul. 13, 2005,disclosing “Fiber optic position and shape sensing device and methodrelating thereto;” U.S. Provisional Pat. App. No. 60/588,336, filed onJul. 16, 2004, disclosing “Fiber-optic shape and relative positionsensing;” and U.S. Pat. No. 6,389,187, filed on Jun. 17, 1998,disclosing “Optical Fibre Bend Sensor,” which are incorporated byreference herein in their entireties. In other alternatives, sensorsemploying other strain sensing techniques such as Rayleigh scattering,Raman scattering, Brillouin scattering, and Fluorescence scattering maybe suitable. In other alternative embodiments, the shape of the cathetermay be determined using other techniques. For example, if the history ofthe catheter's distal tip pose is stored for an interval of time that issmaller than the period for refreshing the navigation display or foralternating motion (e.g., inhalation and exhalation), the pose historycan be used to reconstruct the shape of the device over the interval oftime. As another example, historical pose, position, or orientation datamay be stored for a known point of an instrument along a cycle ofalternating motion, such as breathing. This stored data may be used todevelop shape information about the catheter. Alternatively, a series ofpositional sensors, such as EM sensors, positioned along the cathetercan be used for shape sensing. Alternatively, a history of data from apositional sensor, such as an EM sensor, on the instrument during aprocedure may be used to represent the shape of the instrument,particularly if an anatomical passageway is generally static.Alternatively, a wireless device with position or orientation controlledby an external magnetic field may be used for shape sensing. The historyof its position may be used to determine a shape for the navigatedpassageways.

In this embodiment, the optical fiber may include multiple cores withina single cladding. Each core may be single-mode with sufficient distanceand cladding separating the cores such that the light in each core doesnot interact significantly with the light carried in other cores. Inother embodiments, the number of cores may vary or each core may becontained in a separate optical fiber.

In some embodiments, an array of FBG's is provided within each core.Each FBG comprises a series of modulations of the core's refractiveindex so as to generate a spatial periodicity in the refraction index.The spacing may be chosen so that the partial reflections from eachindex change add coherently for a narrow band of wavelengths, andtherefore reflect only this narrow band of wavelengths while passingthrough a much broader band. During fabrication of the FBG's, themodulations are spaced by a known distance, thereby causing reflectionof a known band of wavelengths. However, when a strain is induced on thefiber core, the spacing of the modulations will change, depending on theamount of strain in the core. Alternatively, backscatter or otheroptical phenomena that vary with bending of the optical fiber can beused to determine strain within each core.

Thus, to measure strain, light is sent down the fiber, andcharacteristics of the returning light are measured. For example, FBG'sproduce a reflected wavelength that is a function of the strain on thefiber and its temperature. This FBG technology is commercially availablefrom a variety of sources, such as Smart Fibres Ltd. of Bracknell,England. Use of FBG technology in position sensors for robotic surgeryis described in U.S. Pat. No. 7,930,065, filed Jul. 20, 2006, disclosing“Robotic Surgery System Including Position Sensors Using Fiber BraggGratings,” which is incorporated by reference herein in its entirety.

When applied to a multicore fiber, bending of the optical fiber inducesstrain on the cores that can be measured by monitoring the wavelengthshifts in each core. By having two or more cores disposed off-axis inthe fiber, bending of the fiber induces different strains on each of thecores. These strains are a function of the local degree of bending ofthe fiber. For example, regions of the cores containing FBG's, iflocated at points where the fiber is bent, can thereby be used todetermine the amount of bending at those points. These data, combinedwith the known spacings of the FBG regions, can be used to reconstructthe shape of the fiber. Such a system has been described by LunaInnovations. Inc. of Blacksburg, Va.

As described, the optical fiber may be used to monitor the shape of atleast a portion of the catheter system 202. More specifically, lightpassing through the optical fiber is processed to detect the shape ofthe catheter system 202 and for utilizing that information to assist insurgical procedures. The sensor system (e.g. sensor system 108 oranother type of tracking system as described in FIG. 3) may include aninterrogation system for generating and detecting the light used fordetermining the shape of the catheter system 202. This information, inturn, in can be used to determine other related variables, such asvelocity and acceleration of the parts of an interventional instrument.The sensing may be limited only to the degrees of freedom that areactuated by the robotic system, or may be applied to both passive (e.g.,unactuated bending of the rigid members between joints) and active(e.g., actuated movement of the instrument) degrees of freedom.

The interventional instrument system may optionally include a positionsensor system 220 (e.g., an electromagnetic (EM) sensor system) whichmay be disabled by an operator or an automated system (e.g., a functionof the control system 112) if it becomes unreliable due to, for example,magnetic interference from other equipment in the surgical suite or ifother navigation tracking systems are more reliable.

The position sensor system 220 may be an EM sensor system that includesone or more conductive coils that may be subjected to an externallygenerated electromagnetic field. Each coil of the EM sensor system 220then produces an induced electrical signal having characteristics thatdepend on the position and orientation of the coil relative to theexternally generated electromagnetic field. In one embodiment, the EMsensor system may be configured and positioned to measure six degrees offreedom, e.g., three position coordinates X, Y, Z and three orientationangles indicating pitch, yaw, and roll of a base point or five degreesof freedom, e.g., three position coordinates X, Y, Z and two orientationangles indicating pitch and yaw of a base point. Further description ofan EM sensor system is provided in U.S. Pat. No. 6,380,732, filed Aug.11, 1999, disclosing “Six-Degree of Freedom Tracking System Having aPassive Transponder on the Object Being Tracked,” which is incorporatedby reference herein in its entirety.

The flexible catheter body 216 includes a channel sized and shaped toreceive an auxiliary tool 226. Auxiliary tools may include, for example,image capture probes, biopsy devices, laser ablation fibers, or othersurgical, diagnostic, or therapeutic tools. Auxiliary tools may includeend effectors having a single working member such as a scalpel, a blade,an optical fiber, or an electrode. Other end effectors may include pairor plurality of working members such as forceps, graspers, scissors, orclip appliers, for example. Examples of electrically activated endeffectors include electrosurgical electrodes, transducers, sensors, andthe like. In various embodiments, the auxiliary tool 226 may be an imagecapture probe including a tip portion with a stereoscopic or monoscopiccamera disposed near the distal end 218 of the flexible catheter body216 for capturing images (including video images) that are processed fordisplay. The image capture probe may include a cable coupled to thecamera for transmitting the captured image data. Alternatively, theimage capture instrument may be a fiber-optic bundle, such as afiberscope, that couples to the imaging system. The image captureinstrument may be single or multi-spectral, for example capturing imagedata in the visible spectrum, or capturing image data in the visible andinfrared or ultraviolet spectrums.

The flexible catheter body 216 may also house cables, linkages, or othersteering controls (not shown) that extend between the instrument body204 and the distal end 218 to controllably bend or turn the distal end218 as shown for example by the dotted line versions of the distal end.In embodiments in which the instrument system 200 is actuated by arobotic assembly, the instrument body 204 may include drive inputs thatcouple to motorized drive elements of the robotic assembly. Inembodiments in which the instrument system 200 is manually operated, theinstrument body 204 may include gripping features, manual actuators, andother components for manually controlling the motion of the instrumentsystem. The catheter system may be steerable or, alternatively, may benon-steerable with no integrated mechanism for operator control of theinstrument bending. Also or alternatively, the flexible body 216 candefine one or more lumens through which interventional instruments canbe deployed and used at a target surgical location.

In various embodiments, the interventional instrument system 200 mayinclude a flexible bronchial instrument, such as a bronchoscope orbronchial catheter for use in examination, diagnosis, biopsy, ortreatment of a lung. The system is also suited for navigation andtreatment of other tissues, via natural or surgically created connectedpassageways, in any of a variety of anatomical systems including thecolon, the intestines, the kidneys, the brain, the heart, thecirculatory system, or the like.

When using a robotic assembly to insert an instrument catheter into apatient anatomy, the outstretched catheter should be supported as thecatheter is advanced into the patient. Otherwise, as the catheter ispushed from a proximal end and encounters friction in the patientanatomy at the distal end, the catheter may buckle or bend. To preventthis deformation of the catheter, an instrument guiding apparatus, asdescribed herein, may be used to provide rigid support to the catheteruntil it enters the patient anatomy. As the catheter enters the patientanatomy, the guiding apparatus peels away from the catheter and moves toan unobtrusive location. Thus, the maximum length of the catheter may beused for patient treatment.

FIG. 3 illustrates an instrument interface portion 300 of a roboticassembly (e.g. robotic assembly 102) and an instrument guiding apparatus302 according to an embodiment of the present invention. The instrumentinterface portion 300 incudes drive inputs 304 to provide mechanicalcoupling of the instrument end effector and flexible body steeringmechanism to the drive motors mounted to the robotic manipulator. Forexample, a pair of drive inputs may control the pitch motion of thedistal end of the instrument flexible body, with one adaptor of the paircontrolling motion in the upward direction and the other of the paircontrolling motion in the opposite downward direction. Other pairs ofdrive inputs may provide opposing motion in other degrees of freedom forthe flexible body and/or the end effector. Instrument interfacing withrobotic manipulators is described, for example in U.S. Pat. No.6,331,181, filed Oct. 15, 1999, disclosing “Surgical Robotic Tools, DataArchitecture, And Use” and U.S. Pat. No. 6,491,701, filed Jan. 12, 2001disclosing “Mechanical Actuator Interface System For Robotic SurgicalTools” which are both incorporated by reference herein in theirentirety. The instrument interface portion 300 may also controlinstrument insertion by moving linearly along an insertion axis A.

The instrument guiding apparatus 302 has a distal end 301 and a proximalend 303. The instrument guiding apparatus 302 includes an elongatedsupport assembly 306 and a mounting strut 307 for coupling theinstrument interface portion 300 to the assembly 306. The instrumentguiding apparatus 302 further includes a return assembly 308. The distalend 301 of the instrument guiding apparatus 302 is shown in detail inFIG. 4 in an initial configuration. The elongated support assembly 306includes lower support component 309 with linkages 310 connected inseries by hinge components 312. In this embodiment, the linkages 310 arearranged in subsets of linkages 314 that form a repeating pattern oflinkages 314 a, 314 b, 314 c, 314 d.

As an example, linkage 314 a is illustrated in detail in FIGS. 6a and 6b. The linkage 314 a includes a projection 316 and a body portion 318.The body portion 318 includes a recessed portion 320 sized and shaped toreceive the projection 316 of a serially connected adjacent linkage(e.g. linkage 314 b). A pin (not shown) extends through an aperture 322in body portion 318 to couple projection 316 of the adjacent linkage,thus hingedly coupling the adjacent linkages. An optional wedgecomponent 324 is sized and shaped to extend into a recess 326 of theadjacent linkage to provide additional longitudinal stability to thelower support component 309. The body portion 318 includes a channelformation 328, a curved edge portion 330, and an interlocking surface332. The interlocking surface 332 may be a generally planar abutmentsurface and/or may include keyed features for interconnection withmating features of a paired linkage. The linkages 310 may be formed ofany of a variety of rigid or semi-rigid materials including metals,polymers, or rubber. Within each subset 314, each linkage has adifferent channel formation and curved edge portion such that whenserially assembled, the curved edge portions form a continuous undulatededge 334.

Referring again to FIG. 4, the elongated support assembly 306 alsoincludes an upper support component 339 having linkages 340 alsohingedly connected in series. The terms “upper support component” and“lower support component” are used only to distinguish the supportcomponents and are not limiting in any way. The linkages 340 arearranged in subsets of linkages 342 that form a repeating pattern oflinkages 342 a, 342 b, 342 c, 342 d. The interlocking surfaces of thelinkages 342 are paired with and interlocked to linkages 314 (e.g.,linkage pair 314 a, 342 a; linkage pair 314 b, 342 b, etc.) such thatthe channel formations of each of the linkages are linearly alignedgenerally along the insertion axis A to form a continuous channelformation 344 through the elongated support assembly 306. The continuousundulated edge 334 of the linkages 314 is spaced apart from a continuousundulated edge 336 of linkages 342. The gap between the undulated edges334, 336 forms an elongated undulating or serpentine opening to thecontinuous channel formation 344. The proximal-most linkages 314 a, 342a in each support component are coupled to a mounting link 343. Themounting link 343 is coupled to the mounting strut 307.

In various alternative embodiments, the subsets of linkages 314 may havefewer or more than four linkages to create a section of a repeatingundulating edge pattern. In other alternative embodiments, the adjacentlinkages in each support component may be coupled by other types ofjoints such as living hinge continuous flexures. In still otheralternative embodiments, the elongated support components may becontinuously formed providing longitudinal structural stability whenaligned along the axis A, but having sufficient flexibility to movearound the return assembly 308. For example, a continuous length ofsemi-rigid material or a notched rigid material may be used. In stillother alternative embodiments, a support assembly may be split intomultiple support components, rather than just two. In still otheralternative embodiments, the length of the support components (and thusthe number of repeating linkage subsets) may be longer or shorter tosupport catheters of different sizes. In still other alternativeembodiments, the diameter of the channel formation 344 may be sized toaccommodate different diameter catheters. In still other alternativeembodiments, the diameter of the channel formation 344 may vary alongits length to match the diameter of a catheter with a diameter varyingalong its length.

In operation, as shown in FIG. 5, movement of the instrument interfaceportion 300 distally along the axis A advances the mounting strut 307which moves the proximal end of the elongated support assembly 306distally. As the proximal end of the elongated support assembly 306 ismoved distally, the linkages 340 are separated from the linkages 310.The separated linkages 340, 310 are directed to the return assembly 308.

The return assembly 308 includes a return guide 350 and a return guide352. In this embodiment, the return guides 350 and 352 are arranged atan approximately 90° angle to each other about the axis A (as seen moreclearly in FIGS. 7 and 8). The return guides 350, 352 are attached to abracket 353. The linkages 310 wrap around the return guide 352 and thelinkages 340 wrap around the return guide 350, directing the linkagesaway from the axis A. As the proximal end of the elongated supportassembly 306 is advanced further distally, linkages 310 moveapproximately 180° around the return guide 352 and the leading linkagesof the linkages 310 begin moving proximally (in a direction generallyopposite the linear motion of the instrument interface portion 300)along an axis B, aligned generally parallel to the axis A. Similarly, asthe linkages 340 move approximately 180° around the return guide 350 andthe leading linkages of the linkages 340 move proximally (in a directiongenerally opposite the linear motion of the instrument interface portion300) along an axis C, aligned generally parallel to the axis A. Inalternative embodiments, the linkages may return at an angle greater orless than 180°.

The return guides 350, 352 may have a circular or elliptical shape sizedto minimize the chordal effect between the linkages and the guides. Inother words, to maintain a relatively consistent velocity of thelinkages around the guides while minimizing any lurching or pulsatingmotion of the linkages, the return guide shape is selected in view ofthe size of the linkages. As shown in FIGS. 9a and 9b , a return guide400 includes circular component 410 having a radius R. The circularcomponent may be rotatable or may be stationary. A rotatable circularcomponent may be powered or passively rotatable. The return guide 400also includes a delivery component 411 that includes entrance and exitramps 405 that direct the linkages onto the return guide. The entranceand exit ramps are sized and shaped to direct the linkages at a constantheight and constant speed onto the return guides. The circular component410 may rotate relative to the delivery component 411. In variousalternative embodiments, the circular component and the deliverycomponent may be a unitary structure with a noncircular curvaturesurface that integrates the entrance and exit ramps with an arc of thecircular component. In other embodiments, the unitary structure with anoncircular curvature may have an elliptical or parabolic curve.

As shown in FIG. 9a , a linkage assembly 401 has linkages 402. As shownin FIG. 9b , a linkage assembly 403 has linkages 404. Generally, thelarger the linkages are, the greater the chordal effect that will beexperienced, if the size of the return guide is held constant. Likewise,a larger radius return guide exhibits less chordal effect than a smallercircle, if the size of the linkages is held constant. Smaller linkages,while often preferable to minimize chordal effect, may result in a lessrigid construction when the linkage assembly is aligned along theinsertion axis A. Thus, the design of the linkage assembly and the sizeof the linkages must take into consideration the (often opposing)factors of chordal effect and linkage assembly rigidity. The size of thereturn guides also affects the length of the proximal end of thecatheter that is retained in the instrument guiding apparatus 302 andthus is unusable for patient treatment. For example, the larger theradius R of the return guide, the greater the length of unusablecatheter.

Optionally, to facilitate the movement of the linkages around the returnguides, one or more push or pull systems may be utilized. For example,the return guides may include a freely-rotating wheel which rotates withthe linkages as the proximal end of the elongated support assembly ismoved distally. In various alternative embodiments, the rotating wheelmay include sprockets, a belt, or other friction-based device that pullsor pushes the linkages around the return guide. Alternatively oradditionally, guiding wires may be attached to the leading linkages ofthe support members 310, 340. As the proximal end of the elongatedsupport assembly is moved distally, the guiding wires pull the leadinglinkages of the support components 309, 339. The guiding wires mayadvance in a generally proximal direction (opposite the direction ofinsertion) along the axes B, C as the instrument interface portion 300moves distally. In various embodiments, the guiding wires may beconnected to the instrument interface portion such that a guiding wire,the instrument interface portion, and a support member form a movingloop.

Referring again to FIGS. 3, 5, 7, and 8 the return assembly 308 furtherincludes a return support 360 extending generally along the axis C. Thereturn support 360 includes a rod member sized to extend through thechannel formation of the upper support component 339, supporting andmaintaining the alignment of the support member as the linkages 340 moveproximally along the axis C. Likewise, the return assembly 308 includesa return support 362 generally aligned along the axis B. The returnsupport 362 includes a rod member sized to extend through the channelformation of the lower support component 309, supporting and maintainingthe alignment of the support member as the linkages 310 move proximallyalong the axis B. The return supports 360, 362 are coupled to andmaintained in generally parallel alignment by a bracket 364. The bracket364 is rigidly coupled to a bracket 366 which extends generally parallelto the insertion axis A. The bracket 366 is rigidly coupled to thebracket 353.

Referring again to FIGS. 4 and 5, an instrument support 354 extendsdistally from the return guide 352 and distally of the location at whichthe linkages 310 separate from the linkages 340. In alternativeembodiments, the instrument support 354 may be supported by the returnguide 350, the bracket 353, and/or the bracket 366.

FIG. 10 illustrates an interventional instrument system 500 (e.g., theinterventional instrument 200) coupled to the robotic interface portion300. FIG. 11 illustrates the interventional instrument 500 andinstrument guiding apparatus 302 coupled to robotic manipulator assembly550 which includes the interface portion 300. The instrument 500 ispositioned in a surgical environment with a patient anatomy P. As shownin FIG. 10, the instrument system 500 includes an elongated flexiblecatheter 502 extending generally along the insertion axis A when theinstrument system is coupled to the robotic interface. To support thelongitudinal length of the catheter during patient insertion, aclinician inserts catheter 502 between the undulated edges 334, 336through the elongated undulated opening and into the channel formation344. The catheter 502 is laterally inserted in a direction generallyperpendicular to the insertion axis A. The catheter 502 is able to flexslightly to conform to the undulated opening. Inside the elongatedsupport assembly 306, the flexible catheter 502 returns to a generallystraight configuration with the channel formations 328 and curved edges380 of the linkages retaining the catheter 502 and preventing it frommigrating from the continuous channel through the undulated opening.Thus, the flexible catheter 205 is laterally received into engagementwith the elongated support assembly 306. As compared to a supportassembly that requires entry of the catheter into the channel formationthrough a proximal opening, the elongated undulated opening also mayallow the catheter 502 to be more efficiently attached and detached fromthe interface portion 300 without the need for moving the interfaceportion proximally along the axis of insertion A. The elongatedside-opening channel also allows a catheter that is already partiallyinserted into a patient to be coupled to the robotic assembly withoutremoving the catheter.

The elongated support assembly 306 may support the catheter 502 alongits complete or partial length. With the support components 309, 339interlocked along the insertion axis A, the support assembly 306minimizes bending or buckling of the catheter 502 as the distal end ofthe catheter 502 is advanced into the patient anatomy P. Any significantbending or buckling of the catheter 502 may damage optical fibers usedfor shape sensing or endoscopy. Also, bending or buckling may makeadvancing the catheter non-intuitive, since the user will observe nodistal tip movement even though the user is advancing the proximal endof the catheter. In the described embodiments, the support components309, 339 form a self-supporting structure that requires no support railsor other rigid, elongated supports along the axis A. Thus, the supportcomponents 309, 339 are able to move out of the path of the advancingrobotic interface portion 300.

As the robotic interface portion 300 is advanced, under a clinician'scontrol, distally along the insertion axis A, it also moves the catheter502 and the proximal end of the elongated support assembly 306 distally.At the distal end 301 of the instrument guiding apparatus 302, thereturn assembly 308 incrementally separates the elongated supportassembly 306 along the axis A into the lower support component 309 whichis routed around the return guide 350 and into the upper supportcomponent 309 which is routed around the return guide 352. As thesupport components 309, 339 are directed away from the axis A, thecatheter 502 continues to advance distally past the distal end 301 ofthe instrument guiding apparatus 302 for insertion into the patientanatomy P. Optionally, the instrument support 354 may support the lengthof the catheter 502 extending between the patient anatomy and the distalend 301 of the instrument guiding apparatus 302. As the catheter isremoved from the patient, the support components 309, 339 move inreverse, reassembling into the interlocked support assembly to supportthe withdrawn catheter.

FIG. 12 provides a method 600 of guiding an interventional instrument(e.g., instrument 500) using the instrument guiding apparatus 302. At602, the method 600 includes receiving a catheter portion of aninterventional instrument system into a support assembly. As describedabove, the catheter portion of the interventional instrument may beinserted through an elongated undulated opening into a continuouschannel formation of the support assembly. The direction of insertionmay be generally perpendicular to the axis of insertion of theinterventional instrument. At 604, the method 600 includes receiving anindication at the robotic control system that the interventionalinstrument system is coupled to the robotic manipulator. At 606, themethod 600 includes advancing the interventional instrument system alongthe insertion axis A. At 608, the method 600 includes incrementallyseparating the distal end of the support assembly into separated firstand second support components. As the support assembly is incrementallyseparated in two, the distal catheter portion of the interventionalinstrument is advanced distally into the patient anatomy. The proximalportion of the catheter remains supported by the interlocked supportassembly. The location at which the support assembly is separated may belocated as dose as is practicable to the entrance to the patient anatomyto limit the length of the catheter that is unsupported between thesupport assembly and the entrance to the patient anatomy. At 610, themethod 600 includes directing the first support component of theseparated support assembly in a first return direction, away from theinsertion axis A. At 612, the method 600 includes directing the secondsupport component of the separated support assembly in a second returndirection, away from the insertion axis A. As previously described, theseparated support components of the support guide may be routed to areturn assembly that directs the support components in differentdirections away from the catheter portion and the insertion axis A.

FIG. 13 illustrates a robotic assembly 650 and an instrument guidingapparatus 652 extending along an insertion axis A1 according to anotherembodiment of the present disclosure. An interventional instrumentsystem 654 (e.g., instrument system 200) includes an adaptor portion 656and a catheter portion 658. In this embodiment, the instrument system654 couples to the instrument guiding apparatus 652 in a lateraldirection, generally perpendicular to the insertion axis A1. The adaptorportion 656 couples to the robotic assembly 650 as previously described.In this embodiment, the catheter portion 658 attaches directly to theinstrument guiding apparatus 652 via, for example, magnetic force,discrete fasteners, or adhesive connection. The catheter portion 658 islongitudinally supported by the guiding apparatus 652 along its length,preventing buckling or bending of the catheter portion. When coupled,catheter portion 658 may be longitudinally fixed (along axis A1) withrespect to the instrument guiding apparatus 652. As such, thelongitudinal movement of the robotic assembly 650 along the insertionaxis A1 moves the catheter portion 658 together with the instrumentguiding apparatus 652, without substantial sliding of the catheterportion relative to the instrument guiding apparatus. In thisembodiment, as the catheter portion 658 enters the patient anatomy, theinstrument guiding apparatus 652 can be separated from the catheterportion 658 and routed away from the axis A1 as a single member. Thelateral attachment of the catheter to the guide apparatus allows aclinician to attach a catheter portion that has already been insertedinto a patient anatomy to the instrument guiding apparatus.

Although the systems and methods of this disclosure have been describedfor use in the connected bronchial passageways of the lung, they arealso suited for navigation and treatment of other tissues, via naturalor surgically created connected passageways, in any of a variety ofanatomical systems including the colon, the intestines, the kidneys, thebrain, the heart, the circulatory system, or the like. The methods andembodiments of this disclosure are also suitable for non-interventionalapplications.

One or more elements in embodiments of the invention may be implementedin software to execute on a processor of a computer system such ascontrol system 112. When implemented in software, the elements of theembodiments of the invention are essentially the code segments toperform the necessary tasks. The program or code segments can be storedin a processor readable storage medium or device that may have beendownloaded by way of a computer data signal embodied in a carrier waveover a transmission medium or a communication link. The processorreadable storage device may include any medium that can storeinformation including an optical medium, semiconductor medium, andmagnetic medium. Processor readable storage device examples include anelectronic circuit; a semiconductor device, a semiconductor memorydevice, a read only memory (ROM), a flash memory, an erasableprogrammable read only memory (EPROM); a floppy diskette, a CD-ROM, anoptical disk, a hard disk, or other storage device. The code segmentsmay be downloaded via computer networks such as the Internet, intranet,etc.

Note that the processes and displays presented may not inherently berelated to any particular computer or other apparatus. The requiredstructure for a variety of these systems will appear as elements in theclaims. In addition, the embodiments of the invention are not describedwith reference to any particular programming language. It will beappreciated that a variety of programming languages may be used toimplement the teachings of the invention as described herein.

While certain exemplary embodiments of the invention have been describedand shown in the accompanying drawings, it is to be understood that suchembodiments are merely illustrative of and not restrictive on the broadinvention, and that the embodiments of the invention not be limited tothe specific constructions and arrangements shown and described, sincevarious other modifications may occur to those ordinarily skilled in theart.

What is claimed is:
 1. A guiding apparatus comprising: a supportassembly extending along a longitudinal axis and including: a firstplurality of linkages including a first channel formation; and a secondplurality of linkages including a second channel formation; wherein thesupport assembly has a coupled configuration with a proximal end and adistal end in which the first plurality of linkages is coupled to thesecond plurality of linkages with the first and second channelformations arranged to form a continuous channel through the supportassembly, wherein the continuous channel has an opening sized to receivean elongated flexible instrument.
 2. The guiding apparatus of claim 1further comprising: a first return assembly; a second return assembly;and a strut having a proximal portion and a distal portion, wherein thedistal portion of the strut is coupled to a proximal end of the firstand second plurality of linkages, wherein advancement of the distalportion of the strut along the longitudinal axis moves the distal end ofthe support assembly from the coupled configuration to a decoupledconfiguration in which a portion of the first plurality of linkages isseparated from a portion of the second plurality of linkages.
 3. Theguiding apparatus of claim 2 wherein the first return assembly includesa curved surface and the second return assembly includes a curvedsurface, wherein the separated portion of the first plurality oflinkages is configured to advance along the curved surface of the firstreturn assembly and the separated portion of the second plurality oflinkages is configured to advance along the curved surface of the secondreturn assembly.
 4. The guiding apparatus of claim 3 wherein the firstreturn assembly further includes a return guide adapted to guide theseparated portion of the first plurality of linkages in a directionapproximately parallel to the longitudinal axis.
 5. The guidingapparatus of claim 1 wherein adjacent linkages of the first plurality oflinkages are pivotably coupled to each other by a hinge.
 6. The guidingapparatus of claim 1 wherein adjacent linkages of the first plurality oflinkages are coupled by a flexible material.
 7. The guiding apparatus ofclaim 1 wherein the first channel formation of the first plurality oflinkages forms a first undulated edge in the coupled configuration. 8.The guiding apparatus of claim 7 wherein the second channel formation ofthe second plurality of linkages forms a second undulated edge in thecoupled configuration, wherein the first and second undulated edges formthe opening of the continuous channel, wherein the opening is sized toreceive the elongated flexible instrument in a direction generallyperpendicular to the longitudinal axis.
 9. The guiding apparatus ofclaim 1 wherein each linkage of the first plurality of linkages includesa first locking feature and each linkage of the second plurality oflinkages includes a second locking feature, wherein, in the coupledconfiguration, each first locking feature interlocks with acorresponding one of the second locking features.
 10. The guidingapparatus of claim 2 wherein the strut extends between the proximal endof the support assembly and an interface portion of a roboticmanipulator.
 11. The guiding apparatus of claim 1 further comprising: aninstrument support extending distally of the coupled first and secondpluralities of linkages.
 12. The guiding apparatus of claim 1 furthercomprising: a return assembly including a noncircular curved surfacewherein the first plurality of linkages is configured to move along thenoncircular curved surface of the return assembly.
 13. The guidingapparatus of claim 1 further comprising: a return assembly including arotatable circular component and a ramping component, wherein the firstplurality of linkages is configured to move along the ramping componentand onto the rotatable circular component.
 14. A method of guiding aninterventional instrument, the method comprising: receiving a portion ofthe interventional instrument through an opening of a continuous channelof a support assembly extending along a longitudinal axis and having aproximal end and a distal end, the support assembly including: a firstplurality of linkages including a first channel formation; and a secondplurality of linkages including a second channel formation, wherein in acoupled configuration, the first plurality of linkages is coupled to thesecond plurality of linkages with the first and second channelformations arranged to form the continuous channel; advancing theproximal end of the support assembly in a first direction along thelongitudinal axis; separating a portion of the first plurality oflinkages from a portion of the second plurality of linkages as a resultof the interventional instrument advancing in the first direction alongthe longitudinal axis; and directing the separated portions of the firstand second pluralities of linkages away from the longitudinal axis. 15.The method of claim 14 wherein directing the separated portions of thefirst and second pluralities of linkages away from the longitudinal axisincludes directing the separated portion of the first plurality oflinkages away from the separated portion of the second plurality oflinkages.
 16. The method of claim 14 wherein directing the separatedportions of the first and second pluralities of linkages away from thelongitudinal axis includes directing the separated portions of the firstand second pluralities of linkages in a second direction approximatelyopposite the first direction and approximately parallel to thelongitudinal axis.
 17. The method of claim 14 further comprising:advancing a distal end of the interventional instrument distally beyondthe separated portions of the first and second pluralities of linkages.18. The method of claim 14 wherein: the first channel formation of thefirst plurality of linkages forms a first undulated edge; the secondchannel formation of the second plurality of linkages forms a secondundulated edge; the first and second undulated edges form the opening ofthe continuous channel; and the portion of the interventional instrumentis received in the opening of the continuous channel in a directiongenerally perpendicular to the longitudinal axis.
 19. The method ofclaim 14 wherein separating the portion of the first plurality oflinkages from the portion of the second plurality of linkages includesseparating a first locking feature of each linkage of the firstplurality of linkages from a corresponding second locking feature ofeach linkage of the second plurality of linkages.
 20. The method ofclaim 14 wherein directing the separated portions of the first andsecond pluralities of linkages away from the longitudinal axis includes:advancing the separated portion of the first plurality of linkages alonga curved surface of a first return assembly; and advancing the separatedportion of the second plurality of linkages along a curved surface of asecond return assembly.